Trial Outcomes & Findings for Therapeutic Approaches to HAART-Induced Lipodystrophy (NCT NCT00461552)

NCT ID: NCT00461552

Last Updated: 2019-05-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-05-09

Participant Flow

Participant milestones

Measure	Leptin Randomized to receive leptin.	Placebo Randomized to receive placebo
Overall Study STARTED	7	7
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Leptin Randomized to receive leptin.	Placebo Randomized to receive placebo
Overall Study Drug Dispensing error	0	2

Baseline Characteristics

Therapeutic Approaches to HAART-Induced Lipodystrophy

Baseline characteristics by cohort

Measure	Leptin n=7 Participants Randomized to receive leptin.	Placebo n=7 Participants Randomized to receive placebo.	Total n=14 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 10.4 • n=5 Participants	48.1 years STANDARD_DEVIATION 3.7 • n=7 Participants	49.3 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Weight	71.2 kg STANDARD_DEVIATION 6.2 • n=5 Participants	75.6 kg STANDARD_DEVIATION 7.8 • n=7 Participants	73.4 kg STANDARD_DEVIATION 7.2 • n=5 Participants
Triglycerides	336 mg/dL n=5 Participants	471 mg/dL n=7 Participants	377 mg/dL n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Leptin n=7 Participants Randomized to receive leptin.	Placebo n=5 Participants Randomized to receive placebo.
Fasting Serum Triglycerides	237 mg/dL Interval 122.0 to 439.0	341 mg/dL Interval 127.0 to 1099.0

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Leptin n=7 Participants Randomized to receive leptin.	Placebo n=5 Participants Randomized to receive placebo.
Body Weight (kg)	68.6 kg Standard Deviation 5.7	73.3 kg Standard Deviation 6.7

Adverse Events

Leptin

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Leptin n=7 participants at risk Randomized to receive leptin.	Placebo n=5 participants at risk Randomized to receive placebo.
Nervous system disorders cerebrovascular accident	14.3% 1/7 • Number of events 1 • 6 months	0.00% 0/5 • 6 months

Other adverse events

Measure	Leptin n=7 participants at risk Randomized to receive leptin.	Placebo n=5 participants at risk Randomized to receive placebo.
Skin and subcutaneous tissue disorders Itching	57.1% 4/7 • Number of events 4 • 6 months	20.0% 1/5 • Number of events 1 • 6 months

Additional Information

Dr. Abhimanyu Garg

UT Southwestern Medical Center

Phone: 214-648-2895

Email: abhimanyu.garg@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60